U.S. Regulators Issue Warning About Canadian Botox

U.S. federal regulators just issued a warning to hundreds of medical practices to be on the look-out for unapproved Botox.

Contacting over 350 medical practices, the U.S. Food & Drug Administration (FDA) wrote that the Botox they received might have come from a Canadian supplier, might be unapproved, and might be counterfeit or dangerous, said CBC News. The FDA letter was sent last month and just made public.

According to the agency, batches of Botox that were shipped by suppliers owned by pharmacy Canada Drugs were not FDA-approved, therefore, the agency could not assure the product’s efficacy or safety, said CBC News. The FDA noted that Canada Drugs had previously been linked to shipping unapproved and counterfeit cancer drugs.

The agency also warned physicians about purchasing medications from sources that were not licensed, U.S. pharmacies—the fifth such warning the FDA has made in 2012, alone, over foreign suppliers providing unapproved drugs, CBC News said. This February, the FDA warned 19 medical practices that they had received a counterfeit version Avastin, a cancer treatment, CBC News explained. The FDA issued similar warnings about counterfeit Avastin and Altuzan—a different brand of the same medication as Avastin—on three occasions. Those alerts primarily targeted drugs distributed by Canada Drugs.

In October, the FDA ordered operators of some 4,100 web sites to cease selling unapproved medications to U.S. consumers—most sites were operated by Canada Drugs. The site was still operational late last week, said CBC News.

Earlier this year, the FDA issued a warning about counterfeit Adderall. The counterfeit version of Teva Pharmaceutical Industries’ Adderall tablets were purchased on the Internet and contain fake active ingredients. The bogus pills were meant to imitate Teva Adderall 30 milligram tablets. Adderall is a prescription medication approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy, and is classified as a controlled substance.

Many are concerned that as drug counterfeiters fine-tune their practices, global health regulators are ill-prepared to prevent fake drugs from reaching patients The law has not caught up with counterfeiters and is not expected to catch up for years to come.

Although this case, and others previously, have involved injectable medications not distributed at the patient level, some cases have involved consumer-level medications, The FDA previously advised consumers to be extra cautious when purchasing medicines from online sources and notes that so-called “rogue” web sites and distributors may be targeting medicines in short supply for counterfeiting.

Genuine Botox is made by Allergan Inc., in Irvine, California. Avastin is made by Roche Holding AG’s Genentech unit, CBC News said.